Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Tsumura & Co. Revised: March 2013 (5th version) 1 Standard Commodity Classification No. of Japan 875200 - Kampo-preparation- TSUMURA Tokikenchuto Extract Granules for Ethical Use <tokikenchuto> Approval No. Date of listing in the NHI reimbursement price Date of initial marketing in Japan Storage Store in light-resistant, air-tight containers. (61AM)1126 October 1986 October 1986 Expiration date Use before the expiration date indicated on the container and the outer package. DESCRIPTION Composition 7.5 g of TSUMURA Tokikenchuto extract granules contains 3.75 g of a dried extract of the following mixed crude drugs. JP Peony Root .................................... 5.0 g JP Cinnamon Bark ............................. 4.0 g JP Jujube ............................................ 4.0 g JP Japanese Angelica Root................. 4.0 g JP Glycyrrhiza ……………………… 2.0 g JP Ginger ………………………...…. 1.0 g (JP: The Japanese Pharmacopoeia) Inactive ingredients Description JP Magnesium Stearate Maltose Syrup Powder Dosage form Granules Color Slightly grayish-brown Smell Characteristic smell Taste Sweet ID code TSUMURA/123 INDICATIONS TSUMURA Tokikenchuto Extract Granules (hereafter TJ-123) is indicated for the relief of the following symptoms of those patients who are easily fatigued and have a poor complexion: Menalgia, lower abdominal pain, hemorrhoids, and pain of proctoptosis DOSAGE AND ADMINISTRATION The usual adult dose is 7.5 g/day orally in 2 or 3 divided doses before or between meals. The dosage may be adjusted according to the patient's age and body weight, and symptoms. PRECAUTIONS 1. Careful administration (TJ-123 should be administered with care in the following patients.) (1) Patients with an extremely weak gastrointestinal tract [Anorexia, epigastric distress, nausea, diarrhea, etc. may occur.] (2) Patients with anorexia, nausea or vomiting [These symptoms may be aggravated.] 2. Important Precautions (1) When TJ-123 is used, the patient’s “SHO” (constitution/symptoms) should be taken into account. The patient’s progress should be carefully monitored, and if no improvement in symptoms/findings is observed, continuous treatment should be avoided. (2) Since TJ-123 contains Glycyrrhiza, careful attention should be paid to the serum potassium level, blood pressure, etc., and if any abnormality is observed, administration should be discontinued. (3) When TJ-123 is coadministered with other Kampopreparations (Japanese traditional herbal medicines), etc., attention should be paid to the duplication of the contained crude drugs. SHO: The term “SHO” refers to a particular pathological status of a patient evaluated by the Kampo diagnosis, and is patterned according to the patient’s constitution, symptoms, etc. Kampo-preparations (Japanese traditional herbal medicines) should be used after confirmation that it is suitable for the identified “SHO” of the patient. 3. Drug Interactions Precautions for coadministration (TJ-123 should be administered with care when coadministered with the following drugs.) Drugs (1) Preparations containing Glycyrrhiza (2) Preparations containing glycyrrhizinic acid or glycyrrhizinates Signs, Symptoms, and Treatment Mechanism and Risk Factors Pseudoaldosteronism is likely to occur. Besides, myopathy is likely to occur as a result of hypokalemia. (Refer to the section “Clinically significant adverse reactions”.) Since glycyrrhizinic acid has an accelerating action on the potassium excretion at the renal tubules, an acceleration of decrease in the serum potassium level has been suggested. 2 Tsumura & Co. 4. Adverse Reactions TJ-123 has not been investigated (drug use investigations, etc.) to determine the incidence of adverse reactions. Therefore, the incidence of adverse reactions is not known. (1) Clinically significant adverse reactions 1) Pseudoaldosteronism: Pseudoaldosteronism such as hypokalemia, increased blood pressure, retention of sodium/body fluid, edema, increased body weight, etc. may occur. The patient should be carefully monitored (measurement of serum potassium level, etc.), and if any abnormality is observed, administration should be discontinued and appropriate measures such as administration of potassium preparations should be taken. 2) Myopathy: Myopathy may occur as a result of hypokalemia. The patient should be carefully monitored, and if any abnormality such as weakness, convulsion/paralysis of limbs, etc. are observed, administration should be discontinued and appropriate measures such as administration of potassium preparations should be taken. (2) Other adverse reactions Incidence unknown Hypersensitivity Rash, Redness, Pruritus, etc. Note 1) Gastrointestinal Anorexia, Epigastric distress, Nausea, Diarrhea, etc. Note 1) If such symptoms are observed, administration should be discontinued. 5. Use in the Elderly Because elderly patients often have reduced physiological function, careful supervision and measures such as reducing the dose are recommended. 6. Use during Pregnancy, Delivery or Lactation The safety of TJ-123 in pregnant women has not been established. Therefore, TJ-123 should be used in pregnant women, women who may possibly be pregnant only if the expected therapeutic benefits outweigh the possible risks associated with treatment. 7. Pediatric Use The safety of TJ-123 in children has not been established. [Insufficient clinical data] PACKAGING Bottles of 500 g 2.5 g 42 packets 2.5 g 189 packets REQUEST FOR LITERATURE SHOULD BE MADE TO: Consumer Information Services Center Tsumura & Co. 2-17-11 Akasaka, Minato-ku, Tokyo 107-8521, Japan Manufactured and Distributed by: Tsumura & Co. 2-17-11 Akasaka, Minato-ku, Tokyo 107-8521, Japan